# FDA Legislation



## ghe-cl (Apr 9, 2005)

Since the thread that raised the FDA tobacco regulation bill recently was closed, I thought I'd post some of the factual information. This is straight from the IPCPR about the legislation and provides some facts about what's happening:

FDA Legislation: With the House having passed legislation giving the FDA authority over tobacco products, the measure is currently being debated on the Senate floor and is expected to pass early next week. It is not expected to be altered significantly by the Senate. The products which will be regulated first by the FDA are cigarettes, roll-your-own cigarette tobacco, and smokeless tobacco. The FDA will publish a final rule regarding those products approximately 180 days (six months) after the legislation is enacted into law. That rule, which will become effective no later than one year after the FDA legislation is enacted, will be almost identical to the rules promulgated by the agency in 1996. 

Should the agency decide to regulate any other tobacco product, it is required to publish a proposed rulemaking in the Federal Register, include supporting justification and findings and provide a comment period of not less than 60 days. No such regulation may take effect before one year after its publication "unless necessary for the protection of the public health."

Beginning three months after enactment of the legislation, flavorings (other than tobacco or menthol) will be banned in cigarettes only. The cost of regulating tobacco products will be provided through user fees assessed on tobacco manufacturers and importers. However, user fees will not be imposed on an industry unless and until it is formally regulated by the FDA. Thus, user fees will be paid initially only by cigarette, ryo cigarette tobacco, and smokeless tobacco companies.


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